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Completed

NCT Number: NCT02631343

Community Kangaroo Mother Care for Improving Child Survival and Brain Development in Low Birth Weight Newborns

While newborn and child survival remains a priority, optimal development of survivors is receiving increasing attention. Interventions that impact both survival and development should be prioritized for action. Kangaroo Mother Care (KMC) improves survival, and potentially neurodevelopment, in preterm and low birth weight infants in hospital settings but its coverage remains low. Innovation is required to allow the community-based delivery of KMC by front-line workers. This could greatly accelerate scale up and sustainability of this intervention in low resource settings.

The proposed randomized trial is planned in a setting where 40% of births take place at home. Early discharge (as early as within 12 hours of birth) is common for facility births, often at the request of families for social and cultural reasons. Many of the hospitals do not have incubators for the care of very small babies.

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Key information

Conditions

Low Birth Weight

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRD, Society for Applied Studies

Palwal, Haryana, 121102, India

About this study

Low birth weight (LBW) infants will be identified through surveillance. Eligible infants will be randomized into the intervention and control groups. Mother in the intervention group will be supported by a ANM-like study workers assisted by ASHA-like study workers to provide Kangaroo mother care (KMC) to their babies at home. Breastfeeding support will also be provided to these mothers by ANM-like study workers. Essential newborn care will be delivered through Government workers in both groups. Survival will be measured in all enrolled infants through contacts at 1, 3, 6 and 12 months of age. Information will also be ascertained on initiation of breastfeeding, exclusive breastfeeding rates, incidence of infection in the neonatal and in the 1-5 months period. Development outcomes (Maternal Depression, Maternal sense of competence, Mother-infant Bonding, Mother-infant interaction, Newborn Behaviour, Infant temperament, Brain development) will be measured at enrolment, 6weeks, 6 and 12 months of age. Growth will be measured at enrolment and at 1, 3, 6 and 12 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mothers and low birth weight ≥1500gms to ≤2250gms

Exclusion criteria

  • Birth weight <1500gms
  • Unable to feed on offering feeds, confirmed by study team
  • Infant has breathing problems or less active
  • Mother does not intend to stay in study area for the next 12 months

Treatment and study plan

KMC

Behavioral

Promotion of, and support for lactation management and skin to skin care as soon as possible after birth by study ANM supported by study ASHA in addition to routine visits by government health workers

Essential newborn care

Other

Primary outcomes

  1. Assessment of maternal depression

    Time frame: 6 weeks

    The depression will be measured using patient health questionnaire-9

  2. Assessment of maternal depression

    Time frame: Assessment of maternal depression at 6 months

    The depression will be measured using patient health questionnaire-9

  3. Assessment of maternal sense of competence

    Time frame: 6 weeks

    Maternal sense of competence will be measured by maternal self efficacy questionnaire

  4. Assessment of maternal sense of competence

    Time frame: Assessment of maternal sense of competence at 12 months

    Maternal sense of competence will be measured by maternal self efficacy questionnaire

  5. Assessment of mother infant bonding

    Time frame: 6 weeks

    Mother infant bonding will be measured by maternal postnatal attachment questionnaire

  6. Assessment of mother infant interaction

    Time frame: 6 months

    Mother infant interaction will be assessed by video recording and subsequent coding of Joint attention task

  7. Assessment of newborn behaviour

    Time frame: 6 weeks

    Assessment of newborn behaviour by Neonatal behavioural assessment scale

  8. Assessment of infant temperament

    Time frame: 6 months

    Assessment of infant temperament by infant temperament scale

  9. Assessment of infant temperament

    Time frame: Assessment of infant temperament at 12 months

    Assessment of infant temperament by infant temperament scale

  10. Assessment of cognitive function by Bayley scale

    Time frame: 6 months

  11. Assessment of cognitive function by Bayley scale

    Time frame: Assessment of cognitive function by Bayley scale at 12 months

  12. Assessment of home environment by PROCESS

    Time frame: 12 months

Secondary outcomes

  1. Neonatal mortality

    Time frame: From birth to 28 days

  2. Early infant mortality

    Time frame: From birth to 6 months

  3. Early initiation of breastfeeding

    Time frame: From birth to 1 month

  4. Proportion exclusively breastfed

    Time frame: 1, 3 and 6 months

  5. Weight and length gain

    Time frame: 1, 3, 6 and 12 months

  6. Incidence of infection in neonatal

    Time frame: 1 month period

  7. Early recognition of illness at 1 month

    Time frame: 1 month period

    Recognition of illness and careseeking will be ascertained from caregivers by using questionnaires

  8. Early and appropriate care seeking practices at 1 month

    Time frame: 1 month period

    Early and appropriate care seeking ascertained from caregivers by using questionnaires

  9. Early recognition of illness at 3 months

    Time frame: Assessed at 3 months data from 1 month upto 3 months

  10. Early and appropriate care seeking practices at 3 months

    Time frame: Assessed at 3 months data from 1 month upto 3 months

  11. Early recognition of illness at 6 months

    Time frame: Assessed at 6 months data from 3 months upto 6 months

  12. Early and appropriate care seeking practices at 6 months

    Time frame: Assessed at 6 months data from 3 months upto 6 months

Sponsors and collaborators

Lead sponsor

Society for Applied Studies

Other

Collaborators

  • Grand Challenges Canada

Registry information

Official study title

A Community-based Model of Delivery of Kangaroo Mother Care for Improving Child Survival and Brain Development in Low Birth Weight Newborns

Acronym: CKMC-DEV

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 16, 2015
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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